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ʻO ka hoʻomaopopoʻana i kaʻikeʻana o FDA a FDA i ka'ōnaehana (UDI) System: nā koi koʻikoʻi a me ka hoʻokō

Nā manaʻo: 0     Mea kākau:ʻO ka Luna Hoʻokumu pūnaewele pūnaewele: 2016-10-05 kumu: Pūnaewele

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I 20 13,ʻo kaʻoihana meaʻai a me ka lāʻau lapaʻau i hoʻokuʻuʻia i kahi kūlana hope loa i hoʻokumuʻia i kahi'ōnaehanaʻike kūʻokoʻa ma o ka hoʻolahaʻana a me ka hoʻohanaʻana. Pono ke kānāwai hope loa e hoʻopili i nā mea hana kelepona e hoʻokomo ai i kahi mea iʻike likeʻole (Udi) ma nā helu kelepona a me nā mea e hāʻawi ai i kahiʻano a iʻole kahi'ē aʻe. Pono e hāʻawiʻia kēlā me kēia UDI i kahi palapala maʻamau a ma kahiʻano e hoʻohana ai i kaʻikepili a me nāʻikepili i hopuʻia (kōkua)ʻenehana. E koiʻia ka UDI e hōʻailonaʻia e hōʻailonaʻia ma kahi polokalamu i manaʻoʻia no ka hoʻohanaʻana, a manaʻoʻia e hoʻoponoponoʻia ma mua o kēlā me kēia hoʻohana. Nā lā ma nā papa inoa o nā mea hana a me nā'āpana e hōʻikeʻia i kahiʻano maʻamau e kūlike ana i nā kūlana honua a me ka hana maʻamau.
ʻO kahi UDI he helu heluʻokoʻa a iʻole nā'āpana alphanumeric a iʻole nā'āpana alphanumeric e loaʻa ana iʻelua mau'āpana:

  • kahi mea i loaʻa i kahi mea hana

  • kahi mea hana huahana (PI), kahi'āpana o ka udi.

    • ka helu nui a iʻole ka helu batch i loko o kahi i hanaʻia ai kahi polokalamu;

    • ka helu helu helu o kahi mea kiko'ī;

    • ka lā hope o kahi mea kiko'ī;

    • ka lā i hanaʻia kahi mea kiko'ī;

    • ʻO ka helu heluʻokoʻa e koiʻia e §1271.290

E hoʻokuʻuʻia nā UDIS i lalo o kahi'ōnaehana i hanaʻia e ka Accuping FDA-Accrediting Agency Agency. Hāʻawi ke kānāwai i kahi kaʻina e pono ai kahi mea noi e noi ana i ka hoʻopiʻiʻana, e pili ana i kaʻikepili e pono ai ka hoʻopiʻiʻana i ka noi.
ʻO kekahi mau mea'ē aʻe a me nā mea koho i hōʻikeʻia ma ke kānāwai hope loa, e hōʻoia ana e mālamaʻia ke kumukūʻai a me nā kaumaha a me nā kaumaha. E hele ka'ōnaehana UDI i nā hanana, ma luna o kahi mau makahikiʻehiku, e hōʻoia i ka hoʻokōʻana a me nā kaumaha i ka manawa kūpono.
E like me ka'āpana o ka'ōnaehana, koiʻia nā mea hana e hoʻouna ai i kaʻike i kaʻikepili o FDA-Global Dance E kauʻia ka gudid i kahi kūlana maʻamau i kaʻikeʻana i nā mea maʻamau no kēlā me kēia polokalamu me ka Udi, a loaʻa wale nō ka mea e loaʻa ai kaʻike i kaʻikepili. ʻAʻole kahi'āpana o ka'ōpala o ka gudid.
Ke hana neiʻo FDA i ka hapa nui o kēiaʻike i loaʻa i ka lehulehu i ka lehulehu, ma kahi hui pūʻana me ka waihona o ka lāʻau lapaʻau. Hiki i nā mea hoʻohana o nā polokalamu lapaʻau ke hoʻohana i ka loaʻaʻana o ka loaʻaʻana o kaʻike a iʻole ka loaʻaʻana o kaʻike e pili ana i nā mea hana. ʻAʻole hōʻike ka UDI, aʻaʻole e loaʻa ka waihona Gudid, e pili ana i kahi mea e hoʻohana ai i kahi mea pilikino.
No kaʻike hou aku ma ka gudid a me Udi eʻoluʻolu eʻike i nā kumuwaiwai UDI kahi e loaʻa ai nā kiʻi haʻawina e kōkua ai, a me nā kumuwaiwai Udi-pili.


A 'Labeler ' kekahi kanaka e kumu e pili ana i kahi mea e hoʻopili ai i kahi mea e hoʻololiʻia ai keʻano o ka hōʻailona a iʻole ka hoʻololiʻana o ka hōʻailona. ʻO ka hoʻohuiʻana o ka inoa o ka inoa o, a i ka leka uila no ka mea,ʻo ka mea e hoʻolaha ana i ka mea hana, me ka hanaʻoleʻana i nā loli no ka hoʻoholoʻana he labler. I ka hapanui o nā manawa,ʻo ka labler ka mea hana i hana, akā he mea hana hoʻopiʻi paha, he haʻawina maʻalahi, he repaggler.
ʻO kaʻike a me kaʻikeʻikepili a me nāʻikepili (Aidc)ʻo ia ka mea i hana i ka Udi a iʻole ka'ōnaehana kamepiula e hiki ke komo i kahi'ōnaehana uila ma ke kaʻina hana uila.

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